1. Technical Field
This invention relates to medical devices and methods that facilitate sealing and closure of punctures and openings in or between tissue structures, the wall of a blood vessel or the wall of a body cavity.
2. Background Information
The control of bleeding during and after surgery is important to the success of the procedure. The control of blood loss is of particular concern if the surgical procedure is performed directly upon or involves the patient's arteries and veins.
Typically, the insertion of a catheter creates a puncture through the vessel wall and upon removal the catheter leaves a puncture opening through which blood may escape and leak into the surrounding tissues. Therefore, unless the puncture site is closed, clinical complications may result leading to increased hospital stays with the associated costs. To address this concern, medical personnel are required to provide constant and continuing care to a patient who has undergone a procedure involving an arterial or venous puncture to ensure that post-operative bleeding is controlled.
A common method of healing the puncture to the vessel is to maintain external pressure over the vessel until the puncture seals by natural clot formation processes. This method of puncture closure typically takes about thirty to ninety minutes, with the length of time usually being greater if the patient is hypertensive or anti-coagulated.
Furthermore, it should be appreciated that utilizing pressure, such as human hand pressure, to control bleeding suffers from several drawbacks regardless of whether the patient is hypertensive or anti-coagulated. In particular, human hand pressure can be uncomfortable for the patient, can result in excessive restriction or interruption of blood flow, and can use costly professional time on the part of the hospital staff. Other pressure techniques, such as pressure bandages, sandbags, or clamps require the patient to remain motionless for an extended period of time and the patient must be closely monitored to ensure the effectiveness of these techniques.
Devices have been disclosed which plug or otherwise provide an obstruction in the area of the puncture (see, for example, U.S. Pat. Nos. 4,852,568 and 4,890,612) wherein a collagen plug is disposed in the blood vessel opening. When the plug is exposed to body fluids, it swells to block the wound in the vessel wall. Other plug-like devices are disclosed, for example, in U.S. Pat. Nos. 5,342,393; 5,370,660; and 5,411,520; and U.S. Publication No. 2002/0077656 A1.
Yet another example of a device for sealing punctures was previously described in U.S. patent application Ser. No. 11/396,377. Specifically, the device included a closure member, such as a collapsible basket, ECM material and a hemostatic material.
Accordingly, medical devices and methods for closing wounds in the vasculature or in the wall of a body cavity, such as a heart chamber, or a body cavity of another organ of a patient are extremely beneficial. Devices having the ability to consistently, reliably, and quickly close the puncture wound eliminate the prolonged bleeding currently associated with such wounds, prevent disposing any occlusive material into the vessel or body cavity, and prevent introducing infectious organisms into the patient's circulatory system.